Device product
LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit Catalog #: L016080109002 (EUA) The LumiraDx SARS-CoV-2 Quality Controls are intended for liquid quality control testing performed on the LumiraDx Instrument when used with the LumiraDx SARS-CoV-2 Ag Test Strip. The Quality Controls provide users with assurance that the device is performing within specification
Z-0135-2023
Product summary
- Firm
- LumiraDx
- Event
- Event 90998
- Status
- Terminated
- Classification
- Class III
- Quantity
- 83 kits
- Official record key
device-enforcement:Z-0135-2023
Official wording
Reason: Assigned vial lot numbers for the incorrect type of product. SARS-CoV-2 & Flu A/B lot numbers were incorrectly assigned to the positive and negative vial lot numbers for SARS-CoV-2 Ag LQCs within batch 2002204017, which should have been assigned SARS-CoV-2 Ag lot numbers resulting in an error message and preventing use of the LQC
Code information: LQC Kit: 2002204017 Positive Control Vial: 1000 1710 0014 0141 Negative Control Vial: 1000 1720 0014 0142 Exp. Date: 01-Mar-2023
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
Assigned vial lot numbers for the incorrect type of product. SARS-CoV-2 & Flu A/B lot numbers were incorrectly assigned to the positive and negative vial lot numbers for SARS-CoV-2 Ag LQCs within batch 2002204017, which should have been assigned SARS-CoV-2 Ag lot numbers resulting in an error message and preventing use of the LQC